A Clinical Trial to Evaluate the Effects of Food on the Bioavailability of CKD-397 in Healthy Male Subjects

NCT ID: NCT02615782

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-05-31

Brief Summary

This study is a randomized, open-label, oral single dosing, two-way crossover clinical trial to evaluate the effects of food on the bioavailability of CKD-397 after a single oral dose in healthy male subjects

Detailed Description

To healthy male subjects of sixteen(16), following treatments are administered dosing in each period and wash-out period is a minimum of 10 days.

Treatment A: CKD-397 1T under Fasting condition Treatment B: CKD-397 1T under Fed condition (high fat meals). Pharmacokinetic blood samples are collected up to 72hrs. Safety and pharmacokinetic are assessed.

Conditions

Benign Prostatic Hypertrophy (BPH)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A group

1. Period 1: CKD-397 1T single oral administration under fasting condition

2. Period 2: CKD-397 1T single oral administration under fed condition (high fat meals)

Group Type: EXPERIMENTAL

CKD-397

Intervention Type: DRUG

CKD-397 1T single oral administration under fasting condition or fed condition(high fat meals)

B group

1. Period 1: CKD-397 1T single oral administration under fed condition (high fat meals)

2. Period 2: CKD-397 1T single oral administration under fasting condition

Group Type: EXPERIMENTAL

CKD-397

Intervention Type: DRUG

CKD-397 1T single oral administration under fasting condition or fed condition(high fat meals)

Interventions

CKD-397

CKD-397 1T single oral administration under fasting condition or fed condition(high fat meals)

Intervention Type: DRUG

Other Intervention Names

Tamsulosin HCl/Tadalafil 0.2/5mg; HARNAL-D Tab. 0.2mg + Cendom® Tab. 5mg

Eligibility Criteria

Inclusion Criteria

1. Healthy male subject older than 19 years at the time of screening.

2. Subjects who BMI more than 17.5kg/m2 and less than 30.5kg/m2 and weight more than 55kg

3. Subjects who signed the informed consent form after understanding fully to hear a detailed explanation in the clinical trial

Exclusion Criteria

1. Subjects who have a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)

2. Subjects who have a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.

3. Subjects who show AST or AST > 2 times upper limit of normal range or eGFR < 60 mL/min/1.73m2

4. Subjects who drink Alcohol > 210g/week within 6 months prior to the screening.

5. Subjects who take the medication involved in other clinical trials or bioequivalence tests within three months before the first dose medication characters.

6. Subjects who show Systolic Blood Pressure ≤100 or ≥150 mmHg or Diastolic Blood Pressure ≤60 or ≥100 mmHg at screening

7. Subjects who have orthostatic hypotension

8. Subjects who have history of drug abuse or drug abuse positive at screening

9. Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.

10. Smoker ( ≥ 20cigarettes/day)

11. Subjects who takes ETC or herb medicine within two weeks or OTC or vitamin supplement within 1 week before the first IP administration

12. Subjects who do the whole blood donation within two months or component blood donation within 1month prior to the first dosing or receive blood transfusion within 1month prior to the first dosing

13. Subjects who can increase risk due to clinical test and administration of drugs or has Severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results

14. Subjects who take organic nitrate medicine regularly or intermittently

15. Patients with genetic degenerative retinal disease including retinitis pigmentosa

16. Subjects who have hypersensitivity to medicines including tadalafil/tamsulosin component or any other medicines(aspirin, antibiotics etc.) or medical history of clinically significant hypersensitivity

17. Patients who lost sight of one eye by Non-arteritic anterior ischemic optic neuropathy(NAION)

18. Subjects with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

19. Subjects who use a trustworthy method of contraception

20. Subjects who is not able to comply with guidelines described in the protocol

21. Subjects who is determined by investigator's decision including laboratory test result or another reason as unsuitable for clinical trial participation

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Kyu Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Domg-A University Hospital

Locations

Dong-A University Hospital

Seo-gu, Busan, South Korea

Countries

South Korea

Other Identifiers

150FDI15031

Identifier Type: -

Identifier Source: org_study_id